Study Evaluating On-Demand Treatment With BeneFIX In Chinese Subjects

Wyeth

Status and phase: Completed; Phase 3

Conditions: Hemophilia B

Treatments: Biological: Benefix

Study type: Interventional

Funder types: Industry

Identifiers

NCT00866606

B1821004

3090A1-3305

Details and patient eligibility

About

This study will evaluate the safety and efficacy of on-demand treatment with BeneFIX in Chinese hemophilia B subjects.

Enrollment: 35 patients

Sex: All

Ages: 6+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subjects equal or more than 6 years of age with mild, moderate or severe hemophilia B (FIX activity: more than 5%, 1-5%, or less than 1%, respectively)
• Subjects with previous exposure to FIX replacement therapy
• If HIV positive, documented CD4 count more than 200/µL within 6 months of study entry

Exclusion criteria

• Diagnosed with any bleeding disorder in addition to hemophilia B
• Current FIX inhibitor or history of FIX inhibitor (defined as >ULN of the reporting laboratory)
• Subject has no history of exposure to FIX products (previously untreated patient [PUP])
• Subject is currently utilizing primary FIX prophylaxis
• Subjects anticipating elective surgery that may be planned to occur in the 6 months following study entry
• Treated with immunomodulatory therapy within 30 days prior to study entry or planned use for the duration of their study participation
• Participated in another investigational drug or device study within 30 days prior to study entry or planned participation for the duration of their study participation
• Subjects with a known hypersensitivity to hamster protein
• Significant hepatic or renal impairment (ALT and AST >5 x ULN, bilirubin >2 mg/dL or serum creatinine >1.25 x ULN)
• Prothrombin Time >1.5 x ULN
• Platelet count <80,000/µL
• Pregnant or breastfeeding women
• Unwilling or unable to follow the terms of the protocol
• Any condition which may compromise the subject's ability to comply with and/or perform study-related activities or that poses a clinical contraindication to study participation, in the opinion of the Investigator or Sponsor

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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35 participants in 1 patient group

Benefix

Experimental group

Description:

Subjects received on-demand treatments with BeneFIX over a 6-month (calendar day) period.

Treatment:

Biological: Benefix